China NMPA Product Recall - Electromagnetic field therapy device

Guangzhou Longzhijie Technology Co., Ltd. initiated a Class III voluntary recall of its Electromagnetic Field Therapy Device (model LGT-2012, batch 2012023-2) in December 2018. This action followed a random inspection by the Guangzhou Huangpu District Food and Drug Administration in July 2018, which identified that the device failed to meet essential performance standards. Specifically, the product did not comply with requirements for radiation emission (item 36.201.1) and electrical fast transient burst (item 36.202.4) as stipulated by the YY0505-2012 standard. Under the regulatory oversight of the National Medical Products Administration (NMPA), the company implemented several corrective actions: issuing product notifications, contacting customers, and recalling all four affected units sold in China. The non-compliant devices are being replaced with the upgraded and qualified LGT-2000B product, which resolves the identified issues. Additionally, Guangzhou Longzhijie Technology Co., Ltd. has discontinued the LGT-2012 model, replacing it with the newly registered LGT-2000B to ensure ongoing product quality and adherence to standards. The company is also conducting an investigation into the root cause of the non-conformance in the returned devices.